Effects of Intravenous Lidocaine on Endometriosis Pain

Mass General Brigham

Status: Completed

Conditions: Endometriosis

Treatments: Drug: IV diphenhydramine; Drug: IV Lidocaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01968694

2010P002903

Details and patient eligibility

About

We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.

This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reproductive age women ages 18 - 50
• Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist using clinical criteria
• Pain for > 6 months
• Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.
• Receiving regular monthly menses (cannot be receiving Depo-provera injections)

Exclusion criteria

• Pregnant or breastfeeding
• On lupron therapy
• History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
• History of seizure disorder
• Significant anxiety, psychosis or other cognitive disorder limiting completion of study procedures
• History of alcohol or substance abuse
• Chronic pain symptoms other than chronic pelvic pain (excluding migraine pain)
• Known hypersensitivity to amide type anesthetics
• Known hypersensitivity to diphenhydramine (benadryl)
• History of treatment with lidocaine or mexiletene
• Having or showing signs and symptoms of liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

IV Lidocaine

Experimental group

Description:

IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes

Treatment:

Drug: IV Lidocaine

IV diphenhydramine

Placebo Comparator group

Description:

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes

Treatment:

Drug: IV diphenhydramine